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Comparison of The Surgical Drain Placement With Use of Kinesiologic Tape

Primary Purpose

Impacted Third Molar Tooth

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Kinesiologic Tape Group
Drain Group
Control Group
Sponsored by
Konya Necmettin Erbakan Üniversitesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Impacted Third Molar Tooth focused on measuring Kinesiology tape, Surgical drain, Pain, Swelling, Trismus

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Older than 18 of age,
  • Asymptomatic bilateral mesioangular impacted mandibular third molar (Pell and Gregory class II, position B)
  • Fully covered with mucosa and bone

Exclusion Criteria:

  • Alcohol abuse,
  • Smoking,
  • Pregnancy,
  • No allergy
  • Presence of acute severe periodontitis.

Sites / Locations

  • Necmettin Erbakan University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Kinesiologic Tape Group

Surgical Drain Group

Control Group

Arm Description

After the routine impacted third molar surgery, the kinesiologic tape will be prepared individually for each patient; it will be cut into three equal strips (approximately 1.6 cm in width) and placed between the clavicle and the tragus-commissura line. Kinesiologic tape will be removed on the second postoperative day, and all sutures on will be removed on 7. postoperative day.

After routine impacted third molar surgery, plastic non-customised drain tube (2-cm long, 2-mm diameter) will be inserted into a vertical incision between the first and second molars and sutured to the vestibular mucosa.

Routine third molar extraction will be performed. No extra procedures will be done after surgery.

Outcomes

Primary Outcome Measures

Swelling will be assessed using paper ruler. Tragus-Pogonion Tragus-Labial Commissura Angulus Mandible-Lateral canthus.
Swelling measurement will be done from the different three region on the face. Tragus-Pogonion Tragus-Labial Commissura Angulus Mandible-Lateral canthus. The swelling measurement will be done preoperatively, postoperative 2nd day, 7th day after the surgery.
Pain will be assessed using a visual analogue scale.
The level of postoperative pain will be evaluated using a 10-cm visual analogue scale , with zero representing no pain and 10 representing excruciating pain. Pain measurement will be done everyday in one week after the surgery.
Trismus will be evaluated using a caliper at maximum mouth opening.
Trismus will be assessed by measuring the maximum interincisal opening (in millimetres) - the distance between the incisal margin of the upper and lower central incisors. Trismus measurement will be done preoperatively, postoperative 2nd day, 7th day after the surgery.

Secondary Outcome Measures

Full Information

First Posted
September 24, 2019
Last Updated
December 23, 2019
Sponsor
Konya Necmettin Erbakan Üniversitesi
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1. Study Identification

Unique Protocol Identification Number
NCT04108559
Brief Title
Comparison of The Surgical Drain Placement With Use of Kinesiologic Tape
Official Title
Comparison of The Surgical Drain Placement With Use of Kinesiologic Tape on Postoperative Pain, Swelling and Trismus in Impacted Mandibular Third Molar Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
August 26, 2019 (Actual)
Primary Completion Date
December 18, 2019 (Actual)
Study Completion Date
December 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Konya Necmettin Erbakan Üniversitesi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigator's purpose was to compare the effects of the surgical drain and kinesiologic tape applications on postoperative morbidity after mandibular third molar surgery.
Detailed Description
A total of 90 patients will be scheduled for impacted third molar surgery. The patients will be divided into 3 groups.All surgeries will be carried out by the same surgeon. Group A will be treated with kinesiologic tape, Group B will be treated with a surgical drainage tube and Group C will be control group. After surgery in control group, routine surgical extraction will be performed.The investigators will compare postoperative pain, swelling, trismus and patients' comfort. The duration of each procedure from the start of the incision to the time of last suture placement will be noted. Patients are recalled on days 2, 7, 14 postoperative pain, facial swelling, maximum mouth opening, wound dehiscence. For the assesment of the pain, visual analog scale will be used. For the swelling evaluation, measurement will be done from the different three region on the face: Tragus-Pogonion Tragus-Labial Commissura Angulus Mandible-Lateral canthus Maximum mouth opening will be noted before and after (one week later) the surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impacted Third Molar Tooth
Keywords
Kinesiology tape, Surgical drain, Pain, Swelling, Trismus

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Kinesiologic Tape Group
Arm Type
Experimental
Arm Description
After the routine impacted third molar surgery, the kinesiologic tape will be prepared individually for each patient; it will be cut into three equal strips (approximately 1.6 cm in width) and placed between the clavicle and the tragus-commissura line. Kinesiologic tape will be removed on the second postoperative day, and all sutures on will be removed on 7. postoperative day.
Arm Title
Surgical Drain Group
Arm Type
Experimental
Arm Description
After routine impacted third molar surgery, plastic non-customised drain tube (2-cm long, 2-mm diameter) will be inserted into a vertical incision between the first and second molars and sutured to the vestibular mucosa.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Routine third molar extraction will be performed. No extra procedures will be done after surgery.
Intervention Type
Procedure
Intervention Name(s)
Kinesiologic Tape Group
Intervention Description
A mucoperiosteal flap will be raised, a conventional rotary handpiece will be used under irrigation for removing the third molar.Primary wound closure will be accomplished using 3-0 silk sutures.The kinesiologic tape will be prepared individually for each patient; it will be cut into three equal strips (approximately 1.6 cm in width) and placed between the clavicle and the tragus-commissura line. The patients will be invited after one week for removing the sutures.
Intervention Type
Procedure
Intervention Name(s)
Drain Group
Intervention Description
A mucoperiosteal flap will be raised, a conventional rotary handpiece will be used under irrigation for removing the third molar.Primary wound closure will be accomplished using 3-0 silk sutures. A plastic non-customised drain tube (2-cm long, 2-mm diameter) will be inserted into a vertical incision between the first and second molars and sutured to the vestibular mucosa. The patients will be invited after one week for removing the sutures.
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
Routine third molar extraction will be performed. No extra procedures will be done after surgery.
Primary Outcome Measure Information:
Title
Swelling will be assessed using paper ruler. Tragus-Pogonion Tragus-Labial Commissura Angulus Mandible-Lateral canthus.
Description
Swelling measurement will be done from the different three region on the face. Tragus-Pogonion Tragus-Labial Commissura Angulus Mandible-Lateral canthus. The swelling measurement will be done preoperatively, postoperative 2nd day, 7th day after the surgery.
Time Frame
Up to 1week
Title
Pain will be assessed using a visual analogue scale.
Description
The level of postoperative pain will be evaluated using a 10-cm visual analogue scale , with zero representing no pain and 10 representing excruciating pain. Pain measurement will be done everyday in one week after the surgery.
Time Frame
Up to 1week
Title
Trismus will be evaluated using a caliper at maximum mouth opening.
Description
Trismus will be assessed by measuring the maximum interincisal opening (in millimetres) - the distance between the incisal margin of the upper and lower central incisors. Trismus measurement will be done preoperatively, postoperative 2nd day, 7th day after the surgery.
Time Frame
Up to 1week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Older than 18 of age, Asymptomatic bilateral mesioangular impacted mandibular third molar (Pell and Gregory class II, position B) Fully covered with mucosa and bone Exclusion Criteria: Alcohol abuse, Smoking, Pregnancy, No allergy Presence of acute severe periodontitis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dilek Menziletoglu, Dr
Organizational Affiliation
Necmettin Erbakan University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bozkurt Ku Isik, Prof Dr
Organizational Affiliation
Necmettin Erbakan University
Official's Role
Study Director
Facility Information:
Facility Name
Necmettin Erbakan University
City
Konya
State/Province
Karatay
ZIP/Postal Code
42050
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparison of The Surgical Drain Placement With Use of Kinesiologic Tape

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